MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE INSERT SET I5R-T5; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	11.01035
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 june 2020: lot 186521: (b)(4) items manufactured and released on 08-aug-2018.Expiration date: 2023-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Considering the mat23061 ((b)(4) devices manufactured with this mat) this is the first event reported of this type.
Event or Problem Description
When the surgeon tried to impact the trial keel with the metal hummer, the tibia fractured vertical.The possible root cause of the fracture was the strong impaction force.Since the fractured bone repositioned after the implantation of tibial implants, the surgery finished without any additional treatment.The surgeon expressed an opinion that he did not feel any resistance force while impacting.The metal hammer was not medacta's device.
Additional Manufacturer Narrative
On 11 august 2020 we have received the items involved in the complaint: the visual inspection confirms the breakage of the gmk efficiency tibia baseplate on the posterior side.As described in the event description, the breakage is compatible with excessive impacting force during tibia keel preparation.In addition it could have happened that the sides of the keel wings have not been properly prepared with the saw blade before to proceed with impactions (as prescribed in the surgical technique).This could generate excessive stress on the plastic instrument till the breakage.Batch review performed on 01 september 2020: gmk efficiency 77.11.0025 trial tibial baseplate s5 lot.Mat24535 considering the mat24535 (b)(4) devices manufactured with this mat) this is the first event reported of this type.

• Brand Name: GMK SPHERE INSERT SET I5R-T5
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10228954
• Report Number: 3005180920-2020-00374
• Device Sequence Number: 13596440
• Product Code: LXH
• UDI-Device Identifier: 07630030878633
• UDI-Public: 07630030878633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2023
• Device Catalogue Number: 11.01035
• Device Lot Number: 186521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR